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EC number: 929-915-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-{[(6-{2,4,6-trioxo-3,5-bis[6-({[4-(prop-2-enoyloxy)butoxy]carbonyl}amino)hexyl]-1,3,5-triazinan-1-yl}hexyl)carbamoyl]oxy}butyl prop-2-enoate
- EC Number:
- 929-915-1
- IUPAC Name:
- 4-{[(6-{2,4,6-trioxo-3,5-bis[6-({[4-(prop-2-enoyloxy)butoxy]carbonyl}amino)hexyl]-1,3,5-triazinan-1-yl}hexyl)carbamoyl]oxy}butyl prop-2-enoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 2019-04-20
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: animals were of comparable weight
- Fasting period before study: at least 16 hours before administration, water was available ad libitum
- Housing: single housing, Makrolon cage, type II
- Diet (e.g. ad libitum): VRF1 (P); SDS Special Diets Services; ad libitum
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: Februar 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
500 mg/kg bw: 10 g/100ml
2000 mg/kg bw: 40 g/100ml
- Justification for choice of vehicle: Good homogeneity in propylene glycol
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw - Doses:
- 500, 2000 mg/kg bw
- No. of animals per sex per dose:
- 500 mg/kg bw: 3
2000 mg/kg bw: 6 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Individual body weight were determined shortly before administration, weekly thereafter and on the last day of observation.
Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Mortality: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights - Statistics:
- Calculations were performed using Microsoft Excel 2010 and cheked with a calculator.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in both 2000 mg/kg bw and the single 500 mg/kg bw test groups.
- Clinical signs:
- other: In all animals of both 2000 mg/kg bw test groups impaired general state and piloerection were observed from hour 3 until hour 4 or 5 after administration. In two animals of the 500 mg/kg bw test group impaired general state and piloerection were noted fr
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of ZQ542231 after oral administration was found to be greather than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 200 and 500 mg/kg bw of the test item ZQ542231 (preparations in propylene glycol) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 500 mg/kg bw in 3 females). No mortality occurred. Impaired general state and piloerection were present in all animals of the high dose group (2000 mg/kg bw) and in two animals of the 500 mg/kg bw dose group. The body weights of the animals increased within the normal range throughout the study period with one exception. The body weight of one animal of the first 2000 mg/kg bw test group increased during the first observation week but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in all animals at the end of the observation period. The acute oral LD50 was calculated to be greather than 2000 mg/kg bw.
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